A variety of polycarbonate bottles, including the popular Nalgene shatter-free bottles contain the chemical bisphenol A. In sufficient quanitities the chemical is believed to disrupt hormones, but the FDA concludes in an early report that the levels in plastics are low enough not to be harmful.

Could a common chemical found in plastics be toxic? -- the FDA says no

There are plenty of health concerns to consider these days. With some doctors worried about the possible effects of cell phones on the human body, components of our everyday lives that seem immovable have been called into question.

Another major health concern is possible toxins from plastics. Some plastics contain chemicals that are carcinogenic and some have speculated that the minute traces of the chemical that leaches into the drinking water steadily with time could cause cancer. Other chemicals are thought to be not primarily carcinogenic, but to disrupt hormones and wreak havoc upon the human body in other ways.

Among the plastics that fall into the latter category are those made by Nalgene. Nalgene leaches a compound bisphenol A, which in animal tests has been shown to lead changes in behavior and the brain and possibly reduce the survival and birth rate of fetuses. It is thought to have similar effects on the human body. Bisphenol A is used in the plastic and in other applications as a hardening agent.

The debate is particularly fierce due to some of household products that contain the chemical -- Nalgene shatter-proof drinking bottles, Nalgene baby bottles, and canned food (bisphenol A is used to seal cans). As these items are all ingested there is much concern that human health may be adversely affected. It is also found in many other household products such as plastic sunglasses and CDs.

Not so, the Food and Drug Administration concluded last Friday. While many are concerned, they say they have reviewed the research and believe the levels of the chemical found in household items to be tolerable by the human body and are not a threat to infants. The conclusions were presented in a draft report on the topic.

The decision was lauded by the American Chemistry Council, a Political Action Committee (PAC) and public relations organization who seeks to improve the chemical industry's image. Steve Henges, an executive director with the council, states, "FDA is the government agency we rely upon to assess food-contact products. They've assessed this issue in great detail and their conclusion is very reassuring."

Critics blasted the report, though; as they say it relied heavily on studies funded by the plastics industry and ignores studies by leading medical experts. Pete Myers, chief scientist for Environmental Health Sciences complains, "It's ironic FDA would choose to ignore dozens of studies funded by [the National Institutes of Health] -- this country's best scientists -- and instead rely on flawed studies from industry."

The FDA decided to revisit the topic on the chemical, which has been used for decades, due to the federal National Toxicology Program decision that there was "some concern" that the chemical could be harmful to infants.

Sufficient levels of bisphenol A can cause negative physiological effects in humans, the FDA did conclude. It also reported that 93 percent of American had traces of bisphenol in their urine, according to the Centers For Disease Control and Prevention. However the FDA concluded that the amount of the chemical leaching from household products falls thousands of times short of harmful levels.

The FDA will continue its analysis of the chemical in September with outside advisers debating the compounds safety at a September meeting. The final report is being anticipated by lawmakers as it may influence their legislation. Canada is currently considering banning the compound in baby bottles and California, New Jersey and at least 10 other states are considering banning its use in children's products.

The outcome will have a significant effect on the chemical industry as 6 million pounds of bisphenol are produced yearly. Dow Chemical, BASF, and Bayer AG are among the largest producers. They and their representative, the American Chemistry Council, hope that the FDA will conclude in its final report that the chemical is not harmful.

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